Challenge Filair® PTFE Hydrophobic Sterile Filters: High Throughput from China Suppliers and Factory

The Challenge IM Capsule Filters are designed to meet the evolving needs of the biopharmaceutical industry, covering five essential series: clarification, pre-filtration & sterilizing-grade, sterile, mycoplasma removal, and gas filtration. With a particle retention capability ranging from 0.1 to 30 µm, these filters effectively address the complete process requirements from cell culture clarification to final product sterilization. Our filters are engineered to support high-temperature steam sterilization and gamma irradiation, making them compatible with a broad spectrum of commonly used biopharmaceutical solvents, Manufactured in our state-of-the-art factory, all molded parts and sealing components are free from colorants and comply with stringent Class VI and ISO 10993 biocompatibility standards. This ensures minimal leachables and extractables for hygienic processing. Each filter undergoes rigorous dual integrity testing during production, utilizing two independent test methods to guarantee a 100% factory pass rate, Our filters adhere to ISO 9001 quality management and GMP standards, successfully passing USP endotoxin, USP / biocompatibility, and USP extractables tests, while posing no animal-derived TSE/BSE risk. As leading suppliers in China, we take pride in the validation of our products by multiple internationally recognized agencies such as SGS and NF, providing fully verified and reliable filtration solutions for the entire biopharmaceutical process